Adam Feuerstein
Intermune: Questions about today's Hep C data
4/1/2008 9:55 AM EDT
More Hepatitis C news this morning:
InterMune (ITMN) wows the early market crowd with hefty viral load reduction data from a 14-day monotherapy study of its Hep C drug ITMN-191. The press release numbers for '191 look as good as Vertex's (VRTX) telaprevir, but '191 can be dosed twice a day, while telaprevir needs to be dosed every 8 hours.
So, continuing the volatile Hep C investment world, Intermune is up big this morning and Vertex was down pre-market but is now in the green in early trading. (The stock did very well yesterday.)
Well, let's just say the fine print matters, which has my eyebrows raised over the real strength of Intermune's '191 data. Bear with me because this is important if you care at all about Hep C investing:
The data Intermune reports this morning gives the "mean maximum reduction" in Hep C viral load '191 in a 14-day monotherapy study. That means Intermune is reporting the best viral load reduction at any time point over the 14 days of dosing. For the 200 mg twice-daily dose, that's a 3.4 log reduction; for the 200 mg three-time daily dose, it's a 3.9 log reduction.
But wait, most companies running 14-day monotherapy Hep C trials report "end of treatment" data on viral load reduction. That's important because you want to see what the drug is doing at the end of 14 days. In other words, is there a rebound effect where the virus is coming back at any time during treatment? This is how Vertex reported its comparable telaprevir data back in May 2005. At the end of 14 days of monotherapy dosing, telaprevir produced a 4.4 log reduction. If Vertex had used "mean maximum reduction," the telaprevir data would have been even stronger.
Intermune clearly has end of treatment data for '191, so why won't they disclose it?
The other things that bug me about today's Intermune data is a complete lack of adverse event/safety reporting. There's nothing at all in the press release except some vague statement that there were no serious adverse events. Really?
And, investors were expecting to see the complete '191 data from this study, including most importantly, the viral kinetic curves, at the Digestive Disease Week conference in May. But this morning, Intermune says the data won't be at the conference. Why?
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